Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction

NCT02378181 | Completed Results DMC

• 2 other identifiers: 1411CDR-1310-07308
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

This study deploys a strategy to develop and evaluate a training-efficient, multimedia patient-centered Health Education Toolkit to promote shared decision making between counselors and patients. An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum useful in group and individual counseling. The proven behavioral interventions will be augmented with health education material focused on medication assisted treatment (MAT). We will assess feasibility and acceptability, and pilot test whether exposure to the Toolkit (TK) can shared decision making conversations, reduce substance use, and increase engagement with MAT.

Conditions

Alcohol Use; Drug Use

Outcome Measures

Primary Outcomes (2)

• Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q)

  Shared decision making score, as measured by the Shared Decision Making Questionnaire (SDM-Q) which uses a 1-6 point scale with higher numbers indicating greater shared decision-making. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor).

  3 months

• Treatment Satisfaction and Acceptability, as Measured by the Satisfaction Survey

  Satisfaction and acceptability of treatment sessions measured on a 1-5 scale with higher scores indicating greater satisfaction. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor).

  3 months

Secondary Outcomes (3)

• Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis

  3 months

• Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS)

  6 weeks, 3 months

• Medication Assisted Treatment (MAT) Initiation, as Measured by a Utilization Review

  3 months

Study Arms (2)

Toolkit (TK)

EXPERIMENTAL

Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).

Behavioral: Health Education Toolkit

Treatment-as-usual (TAU)

ACTIVE COMPARATOR

Patients in the treatment-as-usual (TAU) condition will receive the same number of counseling sessions as patients in the TK condition from participating counselors who have not been trained to use the Health Education Toolkit. Counselors working with patients in this condition will receive a control training of the same length and intensity on recovery topics that are covered in the Health Education Toolkit, but will not be equipped with the Toolkit.

Behavioral: Treatment-as-usual

Interventions

Health Education Toolkit BEHAVIORAL

An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum. The proven behavioral interventions will be augmented with health education material focused on MAT and HIV risk reduction. Together, these materials will comprise the Health Education Toolkit. The Health Education Toolkit (TK) will employ a shared decision making model to encourage 1) increased recovery engagement by patients, and 2) patient engagement in deciding whether to initiate and adhere to MAT.

Toolkit (TK)

Treatment-as-usual BEHAVIORAL

Treatment-as-usual will consist of the same number of counseling sessions as the experimental TK condition, but the counselors working with patients in this condition will not be equipped with the TK materials.

Treatment-as-usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Screening score of at least 16 on the AUDIT
• Meets criteria for a DSM-V substance use disorder as assessed via the MINI Plus 5.0.
• Reports at least two heavy drinking episodes in the previous 4 weeks

You may not qualify if:

• Reports plans to leave the Philadelphia greater metropolitan area within the next 6 months
• Does not speak English
• Unable to provide valid informed consent

Sponsors & Collaborators

• Treatment Research Institute: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Wedge Medical Center

Philadelphia, Pennsylvania, 19126, United States

Location

Kirkbride Center

Philadelphia, Pennsylvania, 19139, United States

Location

Related Links

• Patient-Centered Outcomes Research Institute (PCORI) Project Abstract

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Results Point of Contact

• Title: Adam C. Brooks, Ph.D.
• Organization: Public Health Management Corporation

abrooks@tri.phmc.org

215-399-0636

Study Officials

• Adam C Brooks, PhD

  Treatment Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 4, 2015
• Study Start: August 16, 2016
• Primary Completion: April 15, 2017
• Study Completion: April 15, 2017
• Last Updated: September 1, 2023
• Results First Posted: September 1, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)